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Clinical trialNCT00006325CompletedPhase 1Interventional

Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment54HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Long Beach Memorial (pediatric)

    Long Beach, California, United States

  • Children'S Hosp of Los Angeles/ucla Med Ctr

    Los Angeles, California, United States

  • Los Angeles County - Usc Med Ctr

    Los Angeles, California, United States

  • Ucsf / Moffitt Hosp - Pediatric

    San Francisco, California, United States

  • Connecticut Children'S Med Ctr

    Farmington, Connecticut, United States

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, United States

  • Univ of Miami (pediatric)

    Miami, Florida, United States

  • Children'S Hosp of Boston

    Boston, Massachusetts, United States

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, United States

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, United States

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, United States

  • Schneider Children'S Hosp

    New Hyde Park, New York, United States

  • Harlem Hosp Ctr

    New York, New York, United States

  • Suny Health Sciences Ctr at Syracuse / Pediatrics

    Syracuse, New York, United States

  • Texas Children'S Hosp / Baylor Univ

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
—
Primary completion
—
Completion
31 Mar 2004
Last update posted
1 Nov 2021
Registered enrollment
54
Registry id
NCT00006325

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.